AdJane Biosciences is developing its platform further, by means of multiple programs across viral and bacterial indications to validate its breadth.
discovery
pre-clinical
phase I
phase II
phase III
PHASE I
Our COVID-19 program was based on intranasal co-administration of our Nm-nOMV platform with SARS-CoV-2 spike protein. This program established the first-in-human proof of our platform, as safety, tolerability, and mucosal immunogenicity were demonstrated.
PRE-CLINICAL
Gonorrhea is a high-burden, increasingly untreatable sexually transmitted infection as escalating antimicrobial resistance has eroded traditional treatment options. The WHO has identified gonorrhea as one of the few infections where antimicrobial resistance threatens basic disease control globally. Our gonorrhea vaccine program is based on the expression and display of multiple antigens on a single Nm-nOMV. The program validates the applicability of our platform in the antimicrobial resistance domain and is co-funded by CARB-X, a global non-profit partnership dedicated to accelerating antibacterial innovation in the fight against drug-resistant bacteria.
PRE-CLINICAL
Our Men. B. vaccine program was the first validation of our platform and targets multiple serotypes by expressing and displaying a variation of porA subtypes on Nm-nOMVs. The resulting concept named “NonaMen” was licensed to CDBIO for further development and commercialization on an exclusive basis for the Chinese market.
PRE-CLINICAL
Our Lyme vaccine program is another validation of the ability of our platform to express and display a heterologous antigen in a single-construct Nm-nOMV-based vaccine. Pre-clinical proof of concept using intramuscular administration has been established and was published.
PHASE I
Systemic immunity acts once a pathogen has already entered the body, limiting its spread and preventing severe illness. What it does not provide is immunity at the body’s primary entry points, so pathogens can still take hold there and spread easily to others. In multiple studies mucosal boosting has been shown to create a superior, multi-layered defense compared to repeated systemic injections. AdJane’s Nm-nOMV platform can be used as such mucosal booster, as is described in our White Paper.
PHASE I
Our Nm-nOMV platform carries outer membrane proteins, lipopolysaccharide (LPS), and lipoproteins in their native conformation, closely resembling what the immune system meets during a real infection. This makes them inherently immunogenic and self-adjuvanting. Their pathogen-associated molecular patterns (PAMPs) activate immune responses without needing a separate adjuvant, and their small particulate size (20 – 300 nm) contributes to uptake by mucosal antigen-presenting cells and secretory IgA production, the antibody class that neutralizes pathogens right at the point of entry. This makes our Nm-nOMV platform uniquely suited to be co-administered as an adjuvant to separately formulated antigens. First supportive clinical data were observed in humans during our COVID-19 clinical trial. Furthermore, the Nm-nOMV platform has been preclinically demonstrated to be an effective adjuvant when co-administered with a broad range of viral and bacterial antigens, both via intranasal and intramuscular administration.
DISCOVERY
AdJane continues to develop its platform across multiple dimensions. Beyond the heterologous prime-boost approach studied in Phase 1, AdJane sees potential in the combination of mRNA and Nm-nOMV. The company is therefore actively pursuing the development of proprietary combination methods.